HEALTHCARE REGULATORY & COMPLIANCE

Continual increases and changes in federal and state regulation and enforcement have resulted in particularly challenging times for healthcare providers. Compliance has become a top priority for both providers and payors, and the number of healthcare organizations with robust compliance programs has grown dramatically. Since executives and board members may be held accountable for lapses in compliance, it is no surprise that governance, risk and compliance are priorities.

To address changing laws and regulations governing healthcare, our healthcare team works with you to establish and maintain compliance with applicable standards. We design and implement corporate compliance programs, as well as conduct educational sessions for board members, employees and medical staff. Our attorneys are also called upon to help with Medicare and Medicaid reimbursement issues, Stark law, fraud and abuse cases, HIPAA concerns, and whistleblower claims.

Comprehensive Regulatory & Compliance Management

Our attorneys are experienced and highly skilled in handling the complex legal and regulatory issues unique to healthcare clients.

Clients from Every Corner of Healthcare

Our clients include the following types of organizations and more:

  • Large and small for-profit, nonprofit, and religiously affiliated hospitals.
  • Hospital systems.
  • Regional medical centers.
  • Academic medical centers (teaching and research).
  • Post-acute and long-term care
  • Behavioral health facilities and services.
  • Clinics, including oncology and dialysis clinics.
  • Home care and hospice services.
  • HMOs
  • Pharmaceutical and medical device companies.
  • Durable medical equipment companies.
  • Ambulatory surgery centers.
  • Accountable Care Organizations and Clinically Integrated Networks.
  • Biotechnology companies.

Supporting Your Compliance Efforts From the Beginning

Compliance begins when transactions begin. Many regulations apply to how transactions in the healthcare world are conceived and structured. To help you manage regulatory concerns and avoid noncompliance from the start, we offer these services and more:

  • Advice in structuring transactions to help assure compliance and avoid regulatory concerns.
  • Due diligence review of regulatory and reimbursement issues within the context of mergers, acquisitions and similar transactions.
  • Negotiation and drafting of contracts and other documents in situations where sensitivity to compliance-related issues is necessary.
  • Assistance with physician recruitment and retention strategies.
  • Negotiation of corporate integrity agreements (CIA) and advice regarding compliance with CIAs.
  • Counsel regarding self-disclosure of noncompliance to the fiscal intermediary, OIG or state agency.
  • Assistance in audits of billing, coding and other reimbursement practices.

Counsel to Keep You on Firm Regulatory Footing

The complex, heavily regulated nature of healthcare requires special focus and attention in order to help avoid undue legal and financial risk. Among our comprehensive range of services are the following:

  • Analyzing and counseling clients regarding Stark, Anti-Kickback, False Claims Act, reimbursement and other similar federal and state laws.
  • Reviewing compliance with safe harbor regulations.
  • Assisting clients in complying with the technical, privacy and security requirements of the Health Insurance Portability and Accountability Act (HIPAA) and other privacy and security obligations.
  • Representing institutional providers in licensing matters and healthcare practitioners before state licensing boards.
  • Reimbursement advice concerning coverage and other reimbursement issues..
  • Helping clients understand and apply the regulatory framework governing clinical research and innovations.
  • Compliance counseling regarding prescription drugs, pharmacies and the FDA.
  • Advising regarding compliance with the Emergency Medical Treatment & Active Labor Act (EMTALA). 

When You Are Under Scrutiny

Many of our attorneys serve as outside general counsel for healthcare-related entities. We are sensitive to the strategic and operational issues confronting healthcare providers. While our focus is proactive and designed to avoid problems before they occur, we are also adept at managing legal issues if difficulties arise. We’ve got your back in, among other things:

  • Conducting or assisting with internal investigations.
  • Managing internal investigations stemming from allegations of documentation or billing irregularities, unethical conduct or violations of law or regulations.
  • Responding to government inquiries and documentation requests such as subpoenas.
  • Helping with grand jury, OIG and Medicaid investigations.
  • Resolving litigation, negotiation and settlement of government claims.
  • Preparing advisory opinion requests for submission to the OIG.
  • Counseling regarding whistleblower and related concerns.
  • Advising regarding conflicts of interest and other corporate matters.
  • Responding to complaints and investigations regarding The Emergency Medical Treatment and Labor Act (EMTALA).